Label: BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11489-081-01 - Packager: BCM Ltd
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 20, 2012
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Directions
Directions for sunscreen use
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months of age: Ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. – 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive ingredients
Aqua (Water), C12-15 alkyl benzoate, Glycerin, Dimethicone, Cetearyl glucoside, Isostearyl isostearate, Tribehenin, Butyrospermum parkii (Shea) butter, Propylene glycol, Cetearyl alcohol, Sodium polyacrylate, Potassium cetyl phosphate, Phenoxyethanol, Dimethicone crosspolymer, Caprylyl glycol, Parfum (Fragrance), Citric acid, Dipropylene glycol, Sodium benzoate, Acrylates/vinyl isodecanoate crosspolymer, Ethylhexylglycerin, Potassium sorbate, Tetrasodium EDTA, Sorbitol, Tilia cordata flower extract, Althaea officinalis root extract, Tocopheryl acetate, Silica
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Description
Immediately calms sensitive skin and with continued use reduces skin reactivity.
Active plant extract, Marshmallow, contains natural sugars and polyphenols to help calm skin and leave it less sensitive.
Directions: Use every morning after cleansing. Colour may vary due to natural ingredients. Formulated without parabens.
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INGREDIENTS AND APPEARANCE
BOTANICS SKIN CALMING DAY ULTRA CALM SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.5 g in 50 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 g in 50 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g in 50 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y) TRIBEHENIN (UNII: 8OC9U7TQZ0) SHEA BUTTER (UNII: K49155WL9Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL (UNII: E107L85C40) SODIUM BENZOATE (UNII: OJ245FE5EU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE SODIUM (UNII: MP1J8420LU) SORBITOL (UNII: 506T60A25R) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11489-081-01 1 in 1 CARTON 1 50 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/14/2013 Labeler - BCM Ltd (230780322) Registrant - The Boots Company Plc (218622660) Establishment Name Address ID/FEI Business Operations BCM Ltd 230780322 manufacture(11489-081) , analysis(11489-081)